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StrataXRT in Preventing Radiation Dermatitis in Pediatric Patients Undergoing Radiation Therapy to the Brain or Spinal Cord

Primary Purpose

Central Nervous System Sarcoma, Ependymoma, Glioma

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo Administration
Questionnaire Administration
Wound Dressing Material
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Central Nervous System Sarcoma

Eligibility Criteria

2 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Pediatric patients between the ages of 2 years old and 17 years old
  • Patients diagnosed with primary CNS tumors including medulloblastoma, pineoblastoma, ependymoma, intracranial germ cell, glioma or intracranial sarcoma who will be starting proton CSI
  • Patients planned to receive at least 20 Gy CSI at 1.8 - 2.0 Gy per fraction
  • Patients with an identified adult (aged 18 years or older caregiver)(familial or other) who consents to apply the StrataXRT and placebo twice a day for the duration of the study and complete the study instruments
  • Informed consent by parents or legal guardian; consent documents will be translated with non-English speaking participants

Exclusion Criteria:

  • Patients who have already started proton CSI treatment
  • Patients receiving > 10 fractions photon therapy
  • Patients with pre-existing dermal scarring, as determined by a clinical member of the study staff
  • Patients who only have a primary caregiver who is a minor (e.g. mother under the age of 18)
  • Patients planned to receive less than 20 Gy CSI at 1.8-2.0 Gy per fraction

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (StrataXRT, placebo)

Arm Description

Beginning first day of CSI proton radiation therapy, caregivers apply StrataXRT gel to half of the patient's forehead and one ear and placebo to the other half of the forehead and the other ear BID until the last day of radiation therapy.

Outcomes

Primary Outcome Measures

Incidence of adverse events
Graded per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Safety will be summarized with standard summary statistics by adverse event (AE), grade, relation, etc. using the CTCAE 5.0. All summaries will be calculated for each control and experimental forehead and ears.
StrataXRT as a preventative agent for radiation-associated dermatitis
To estimate the efficacy of StrataXRT among pediatric patients.

Secondary Outcome Measures

Dosing of StrataXRT
Parent-reported symptom experience
Will be measured by the Radiation-Induced Skin Reaction Assessment Scale (RISRAS). The RISRAS Radiation-Induced Skin Reaction Assessment Scale will be summarized by control and experimental ears at each time point (baseline, 5 weekly treatment visits, and at treatment completion visit [last day of radiation therapy]).
Compliance
As documented in a study log by participants.

Full Information

First Posted
June 17, 2019
Last Updated
November 28, 2020
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03990597
Brief Title
StrataXRT in Preventing Radiation Dermatitis in Pediatric Patients Undergoing Radiation Therapy to the Brain or Spinal Cord
Official Title
A Pilot Study of StrataXRT, a Topical Silicone Barrier, to Prevent Auricular Radiation Dermatitis in Pediatric Patients Undergoing Proton Cerebrospinal Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Per PI
Study Start Date
August 19, 2019 (Actual)
Primary Completion Date
November 24, 2020 (Actual)
Study Completion Date
November 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This phase I trial studies the side effects of a silicone topical wound dressing (StrataXRT) and to see how well it works in preventing radiation dermatitis (skin burns and side effects caused by radiation) in pediatric patients undergoing radiation therapy. StrataXRT may help prevent or decrease severe skin rash, pain, itching, skin peeling, and dry skin in pediatric patients undergoing radiation therapy to the brain or spinal cord.
Detailed Description
PRIMARY OBJECTIVES: I. To estimate the safety (defined using the Common Terminology Criteria for Adverse Events [CTCAE], version 5.0) of StrataXRT and placebo by assessing gel-associated toxicities among pediatric patients, aged 2-17 undergoing proton cerebrospinal irradiation (CSI) for central nervous system (CNS) tumors. II. To estimate the efficacy of StrataXRT as a preventative agent for radiation-associated dermatitis among pediatric patients, aged 2-17 undergoing proton CSI for CNS tumors. SECONDARY OBJECTIVES: I. To explore the relationship between dosing and the efficacy of StrataXRT. II. To explore the relationship between the use of StrataXRT and parent-reported symptom experience, as measured by the Radiation-Induced Skin Reaction Assessment Scale (RISRAS). III. To explore compliance with the application of treatment as documented in a study log by participants. OUTLINE: Beginning first day of CSI proton radiation therapy, caregivers apply StrataXRT gel to half of the patient's forehead and one ear and placebo to the other half of the forehead and the other ear twice daily (BID) until the last day of radiation therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Nervous System Sarcoma, Ependymoma, Glioma, Malignant Intracranial Germ Cell Tumor, Medulloblastoma, Pineoblastoma, Primary Central Nervous System Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (StrataXRT, placebo)
Arm Type
Experimental
Arm Description
Beginning first day of CSI proton radiation therapy, caregivers apply StrataXRT gel to half of the patient's forehead and one ear and placebo to the other half of the forehead and the other ear BID until the last day of radiation therapy.
Intervention Type
Other
Intervention Name(s)
Placebo Administration
Other Intervention Name(s)
placebo, placebo therapy, PLCB, sham therapy
Intervention Description
Applied topically
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Drug
Intervention Name(s)
Wound Dressing Material
Other Intervention Name(s)
Wound Dressing
Intervention Description
Applied StrataXRT topically
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
Graded per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Safety will be summarized with standard summary statistics by adverse event (AE), grade, relation, etc. using the CTCAE 5.0. All summaries will be calculated for each control and experimental forehead and ears.
Time Frame
Up to 6 weeks
Title
StrataXRT as a preventative agent for radiation-associated dermatitis
Description
To estimate the efficacy of StrataXRT among pediatric patients.
Time Frame
Up to 6 weeks
Secondary Outcome Measure Information:
Title
Dosing of StrataXRT
Time Frame
Up to 6 weeks
Title
Parent-reported symptom experience
Description
Will be measured by the Radiation-Induced Skin Reaction Assessment Scale (RISRAS). The RISRAS Radiation-Induced Skin Reaction Assessment Scale will be summarized by control and experimental ears at each time point (baseline, 5 weekly treatment visits, and at treatment completion visit [last day of radiation therapy]).
Time Frame
Up to 6 weeks
Title
Compliance
Description
As documented in a study log by participants.
Time Frame
Up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pediatric patients between the ages of 2 years old and 17 years old Patients diagnosed with primary CNS tumors including medulloblastoma, pineoblastoma, ependymoma, intracranial germ cell, glioma or intracranial sarcoma who will be starting proton CSI Patients planned to receive at least 20 Gy CSI at 1.8 - 2.0 Gy per fraction Patients with an identified adult (aged 18 years or older caregiver)(familial or other) who consents to apply the StrataXRT and placebo twice a day for the duration of the study and complete the study instruments Informed consent by parents or legal guardian; consent documents will be translated with non-English speaking participants Exclusion Criteria: Patients who have already started proton CSI treatment Patients receiving > 10 fractions photon therapy Patients with pre-existing dermal scarring, as determined by a clinical member of the study staff Patients who only have a primary caregiver who is a minor (e.g. mother under the age of 18) Patients planned to receive less than 20 Gy CSI at 1.8-2.0 Gy per fraction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan L McGovern
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

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StrataXRT in Preventing Radiation Dermatitis in Pediatric Patients Undergoing Radiation Therapy to the Brain or Spinal Cord

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